The following Structured Product Label (SPL) was submitted to the FDA by Seajewels Llc for the product Sea Jewels Lemon Balm Full Body Salve (NDC 87060-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients – sea jewels lemon balm full body salve (0.5 oz), purpose – sea jewels lemon balm full body salve (0.5 oz), indications & usage – sea jewels lemon balm full body salve (0.5 oz), warnings – sea jewels lemon balm full body salve (0.5 oz), when using – sea jewels lemon balm full body salve (0.5 oz), do not use – sea jewels lemon balm full body salve (0.5 oz), stop use – sea jewels lemon balm full body salve (0.5 oz), keep out of reach of children – sea jewels lemon balm full body salve (0.5 oz), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Melissa officinalis (Lemon Balm) – Skin protectant
Melaleuca alternifolia (Tea Tree) oil – Antimicrobial
Eucalyptus globulus (Eucalyptus) oil – Soothing agent
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Skin protectant / Antimicrobial / Soothing
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
- Helps comfort skin during periods of irritation or flare-ups
- Helps relieve symptoms associated with:
• Cold sores and herpes outbreaks
• Eczema and rashes
• Ringworm and fungal irritation
• Minor boils and abscesses
• Insect bites
• Shingles flare-ups
• Minor burns
See uploaded back label image.
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For external use only
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Avoid contact with eyes
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Do not use on deep puncture wounds or serious burns
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Stop use if condition worsens or rash develops
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
- Cleanse affected area before application
- Apply a thin layer 2–3 times daily, or as needed
- For open wounds, apply and cover with sterile gauze
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Burdock Root, Oregano Leaf, Organic Flax Seeds, Jojoba Oil (100% Pure Cold-Pressed), Vitamin E Oil, Organic Argan Oil, Grapeseed Oil (100% Pure Cold-Pressed), Organic Coconut Oil, Organic Beeswax
See uploaded back label image.
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Store at room temperature, away from direct sunlight
See uploaded back label image.
Otc Active Ingredients 0.5oz (Backlabel 0.5oz 1080x1080)
Active ingredients
Melissa officinalis (Lemon Balm) – Skin protectant
Melaleuca alternifolia (Tea Tree) oil – Antimicrobial
Eucalyptus globulus (Eucalyptus) oil – Soothing agent
See uploaded back label image
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Skin protectant / Antimicrobial / Soothing
See uploaded back label image
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Helps comfort skin during periods of irritation or flare-ups
Helps relieve symptoms associated with:
• Cold sores and herpes outbreaks
• Eczema and rashes
• Ringworm and fungal irritation
• Minor boils and abscesses
• Insect bites
• Shingles flare-ups
• Minor burns
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
For external use only
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Avoid contact with eyes.
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Do not use on deep puncture wounds or serious burns
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Stop use if condition worsens or rash develops
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Cleanse affected area before application
Apply a thin layer 2–3 times daily, or as needed
For open wounds, apply and cover with sterile gauze
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Burdock Root, Oregano Leaf, Organic Flax Seeds, Jojoba Oil (100% Pure Cold-Pressed),
Vitamin E Oil, Organic Argan Oil, Grapeseed Oil (100% Pure Cold-Pressed),
Organic Coconut Oil, Organic Beeswax
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Store at room temperature, away from direct sunlight
See uploaded back label image.
Package Label.drug Facts – Back Label 4oz (Backlabel 4oz)
Sea Jewels Lemon Balm Full Body Salve
Net Wt. 14.17 g (0.5 oz)
See uploaded fron label images.
Distributed by:
SEAJewels LLC
Stone Mountain, GA 30087
Email: [email protected]
See uploaded back label image.
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Sea Jewels Lemon Balm Full Body Salve
Net Wt. 113.4 g (4 oz)
See uploaded front label image.
Package Label Principal Display Panel 4oz (Frontlabel 4oz)
Distributed by:
SEAJewels LLC
Stone Mountain, GA 30087
Email: [email protected]
See uploaded side panel label image.
Package Label.side Panel 4oz (Sidelabel 4oz)
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